When a DMARD fails, should patients switch to sulfasalazine or add sulfasalazine to continuing leflunomide?

被引:45
作者
Dougados, M
Emery, P
Lemmel, EM
Zerbini, CAF
Brin, S
van Riel, P
机构
[1] Univ Paris 05, Hop Cochin, F-75679 Paris 14, France
[2] Univ Leeds, Sch Med, Leeds LS2 9JT, W Yorkshire, England
[3] Max Grundig Clin, Buhl, Germany
[4] Hosp Heliopolis, Sao Paulo, Brazil
[5] Lab Aventis, Paris, France
[6] Univ Med Ctr Nijmegen, Nijmegen, Netherlands
关键词
D O I
10.1136/ard.2003.016709
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: To evaluate the efficacy and safety of adding sulfasalazine to leflunomide treatment compared with switching to sulfasalazine alone in patients with RA with an inadequate response to leflunomide monotherapy. Methods: Patients with active RA ((DAS28) >3.2) who were enrolled in the first open label phase of the RELIEF study received leflunomide for 24 weeks. Inadequate responders then entered the double blind phase and received a further 24 weeks' treatment with leflunomide ( 20 mg once daily) plus sulfasalazine ( final dose 2 g once daily), or placebo plus sulfasalazine ( dose as above). The primary efficacy variable was the DAS28 response rate, and secondary efficacy outcomes were ACR 20%, 50%, and 70% response rates. Adverse events, including standard laboratory tests, were recorded. Results: 106 inadequate responders entered the double blind phase; 56 received leflunomide plus sulfasalazine, and 50 placebo plus sulfasalazine. In the intention to treat population, more patients receiving leflunomide plus sulfasalazine (25/56 (45%)) achieved a DAS28 response than those receiving placebo plus sulfasalazine ( 17/50 (34%)) ( p = 0.179). In week 24 completers, more patients receiving leflunomide plus sulfasalazine ( 17/56 (30%)) were DAS28 responders than those receiving placebo plus sulfasalazine (10/50 ( 20%)) ( p = 0.081). Comparable numbers in each group were ACR 20% responders; the ACR 50% response rate was significantly higher in the leflunomide plus sulfasalazine group (8.9%) than in the placebo plus sulfasalazine group (0%) ( p = 0.038). The safety profiles of both groups were comparable. Conclusion: Patient numbers are small and firm conclusions cannot be reached, but a non-significant benefit is indicated for combining leflunomide with sulfasalazine compared with switching to sulfasalazine alone in patients inadequately responding to leflunomide.
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页码:44 / 51
页数:8
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